A New Website for Australian IVF Patients: 'Evidence-based IVF'

A New Website for Australian IVF Patients 'Evidence-based IVF': an Online Randomised Trial

IVF 'add-ons' are extra procedures, techniques, or medicines offered alongside standard IVF treatments, often marketed to improve success rates. Examples include EmbryoGlue, endometrial scratching, and acupuncture. However, most lack clear evidence of effectiveness or safety. Despite this, over 80% of Australian IVF patients use add-ons, sometimes paying thousands of dollars.

Patients often rely on clinic websites and online forums for information, but these sources frequently exaggerate benefits while omitting information about costs and risks. There is no independent, evidence-based resource in Australia to guide decision-making, a gap recognized by both patients and government reports.

To address this, the investigators developed "Evidence-Based IVF (EBI)," a new website informed by patient decision aid standards, expertise in digital health and risk communication, and co-design sessions with IVF patients and professionals. The investigators now plan to evaluate how well it helps patients understand the evidence base for IVF add-ons.

Study Overview

• Status: Completed
• Conditions: IVF; IVF Treatment; IVF-ET; IVF/ICSI
• Intervention / Treatment: Other: Evidence-based IVF website content; Other: Control

Detailed Description

In response to widespread calls for evidence-based resources about IVF options and add-ons in Australia, the investigators assembled a multidisciplinary team to co-design a novel website prototype referred to as 'Evidence-based IVF (EBI)'. Informed by patient decision aids standards, the MAGIC App, and applying the investigators' expertise in digital and risk communication and evidence-informed health decisions, the investigators undertook interviews with Australian IVF patients and professionals to test and iteratively modify a new resource. This trial will evaluate how this website performs in terms of gist knowledge and acceptability.

• Study Type: Interventional
• Enrollment (Actual): 1217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3052
      • MDHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Live in Australia
• Undergone IVF/embryo transfer in the last 2 years or planning IVF/embryo transfer in the next six months. IVF refers to any IVF/ICSI/embryo transfer cycle in which the participant or their partner is planning to get pregnant.

Exclusion Criteria:

• People who underwent IVF process for egg-freezing or embryo freezing and not intending to conceive, or who received an embryo transfer as a surrogate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evidence-based IVF information	Other: Evidence-based IVF website content; The Evidence-based IVF website has been developed through a robust co-design process with IVF patients and clinicians, and the information about effectiveness and safety of add-ons was produced following established systematic review methodology of Cochrane (including risk of bias, GRADE, and TRACT assessment). They will view information about one of the following IVF add-ons: Endometrial receptivity array (ERA test), EmbryoGlue, or intralipid.
Active Comparator: Control; Control information	Other: Control; Participants will view information that has been generated by combining information from the top 3 websites retrieved on Google search of the add-on name. They will view information about one of the following IVF add-ons: Endometrial receptivity array (ERA test), EmbryoGlue, or intralipid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gist comprehension using bespoke 5-item questionnaire	5-item measure, correct answer = 2 points per item, max of 10 points, higher score means better comprehension Items 1-3. How does [EmbryoGlue/Intralipid/ERA test] affect the chance of [getting pregnant/having a baby/having a miscarriage] from IVF?; Increases the chance; Possibly increases the chance; Has no effect on the chance; Possibly decreases the chance; Decreases the chance; Its unclear; I don't know4. The scientific studies of [EmbryoGlue/Intralipid/ERA test] are; High quality and very reliable; Moderate quality and reliable; Low quality and somewhat reliable; Very low quality and not at all reliable; I don't know5. [EmbryoGlue/Intralipid/ERA test] is associated with the following risks; Headache; Infection; Pain or discomfort; Nausea and vomiting; Fever or chills; Hair loss Developed from Smith 2012	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with correct comprehension of magnitude of effect	An assessment of understanding of the magnitude of possible benefit as an absolute risk difference. "For every 100 people having IVF, roughly how many more would [get pregnant/have a baby/have a miscarriage] using EmbryoGlue?; 5 more; 10 more; 20 more; The evidence is unclear; I don't know" (Only relevant for EmbryoGlue)	24 hours
Proportion of participants with correct understanding of populations IVF add-on is applicable to	"[EmbryoGlue/Intralipid/ERA test] is relevant to (tick all that apply); Thin lining or thin endometrium; Recurrent implantation failure; Older female age; Sperm or fertilization problems; I don't know"	24 hours
Proportion of participants with correct comprehension of cost of IVF add-on	Expected cost of the add-on "[EmbryoGlue/Intralipid/ERA test] usually costs; Less than $500 AUD; Between $500-$1000 AUD; More than $1,000 AUD; I don't know"	24 hours
Information satisfaction	How satisfied participants are with the information. Items will be combined to give a composite score out of 5 (higher score = more satisfaction). "Please indicate below what you thought about the information for each of the below categories The information was…; Comprehensive; Important; Helpful; Trustworthy; Balanced; Clear and easy to understand" (each rated on 5-point scale from Strongly Disagree to Strongly Agree)	24 hours
Emotional response	Emotional response measured using the Berlin Emotional Responses to Risk instrument (Petrova 2023). Items will be combined to give a composite score out of 5 (higher score = better emotional response), with relevant items reverse scored. "How did you feel when you read the information about [EmbryoGlue/Intralipid/ERA test]?; Assured; Hopeful; Relieved; Anxious; Afraid; Worried" (each measured on a 5-point scale from Strongly Disagree to Strongly Agree) Petrova D, Cokely ET, Sobkow A, Traczyk J, Garrido D, Garcia-Retamero R. Measuring feelings about choices and risks: The Berlin Emotional Responses to Risk Instrument (BERRI). Risk Anal. 2023 Apr;43(4):724-746. doi: 10.1111/risa.13946. Epub 2022 May 23. PMID: 35606164.	24 hours
Hypothetical willingness to speak to IVF specialist about using the add-on	"If I was planning another IVF cycle or embryo transfer, I would speak to my IVF specialist about using [EmbryoGlue/Intralipid/ERA test]" Measured on a 5 point scale from Strongly Disagree to Strongly Agree	24 hours
Self-assessed comprehension	A measure of how well participant believes they understood information provided "After reading this information, how well do you feel you understand the potential benefits and risks of [EmbryoGlue/Intralipid/ERA test]?; Not at all; A little; Somewhat; Mostly; Completely"	24 hours
Information length	Participants perspective on whether information provided was of appropriate length "How would you rate the length of information on the website?; Much too short; A little too short; About right; A little too long; Much too long"	24 hours
Recommend this information	Whether participant would be likely to recommend the information to people considering the add-on "Would you recommend this information to other people having IVF who are considering [EmbryoGlue/Intralipid/ERA test]?; Yes; Maybe; No"	24 hours

Collaborators and Investigators

• Sponsor: University of Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Actual): April 6, 2025
• Study Completion (Actual): April 6, 2025

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: IVF add-ons; Evidence-based IVF
• Other Study ID Numbers: 2025-31333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All survey data that does not contain personal data will be available
• IPD Sharing Time Frame: January 2026 and available for 5 years
• IPD Sharing Access Criteria: Data/information from this research project may also be used in future projects that are closely related to this project, the same general area, or could make valuable use of this data. De-identified data may be shared with other researchers upon reasonable request to Sarah Lensen.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No